Those wishing to participate in the registry as independent investigational site will be required to obtain approval of the FDA-authorized protocol from their reviewing IRB, and complete a written investigator agreement. In addition, sites will be selected for participation in the registry based on:
1) Experienced clinical/academic centers with expertise in MR imaging and electrophysiology.
2) Sufficient MRI volume to enroll 25-50 cases in a one-year period.
3) Availability of competent clinical support staff to maintain timely data entry and FDA documentation.
4) Cardiologist or other qualified physician with a working knowledge of pacemaker function and willingness to participate in the study.
Qualifications for the participating clinical site Principal Investigator:
1) Board certified general cardiologist, a cardiologist with subspecialty training in cardiac electrophysiology, or other qualified physician with appropriate training and experience to supervise the performance of the protocol.
2) Able to interrogate an implanted cardiac device with the assistance of an industry device representative.
3) Able to program/reprogram implanted cardiac device parameters with the assistance of an industry device representative.
4) Able to place and utilize a temporary external cardiac pacemaker.
5) Hospital privileges to place a temporary transvenous cardiac pacemaker.
Alternatively, if you are unable to participate as an investigational site for the project, you may wish to refer patients with cardiac devices that require MRI to Scripps Clinic or other investigational sites participating in the registry.
The MagnaSafe registry is listed on http://clinicaltrials.gov/ .